PremierPro Surgeons Glove - Latex Underglove, PF, Size 7.5, PairColor - SVS LLC

Duns Number:831375089

Device Description: Latex Underglove, PF, Size 7.5, PairColor Green50pair/box, 4bx/case

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More Product Details

Catalog Number

44275

Brand Name

PremierPro Surgeons Glove

Version/Model Number

44275

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

KGO

Product Code Name

Surgeon'S Gloves

Device Record Status

Public Device Record Key

049c205a-22d6-4474-82de-1a430304215b

Public Version Date

June 19, 2020

Public Version Number

2

DI Record Publish Date

January 11, 2019

Additional Identifiers

Package DI Number

20811220031088

Quantity per Package

200

Contains DI Package

10811220031081

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

cs

"SVS LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 486
2 A medical device with a moderate to high risk that requires special controls. 177
U Unclassified 1